BiBBInstruments AB announced that the pilot study EDMX01 with EndoDrill GI has been published in the peer reviewed Scandinavian Journal of Gastroenterology. The study results show 100% diagnostic accuracy when sampling with EndoDrill GI and superseded samples taken in the same tumors with a leading standard biopsy instrument. The authors concluded that the EndoDrill device was safe and easy to use, could obtain true core biopsies in a single pass, with a potential of reducing the need of multiple samplings.

Currently, FDA-cleared, and CE-marked EndoDrillGI is being evaluated at hospitals in the US and Sweden. The results from BiBB's Swedish clinical pilot study, EDMX01, with EndoDrill GI, were announced in the form of a poster presentation at Digestive Disease Week (DDW) in San Diego on May 21-22, 2022. Now, an original article with more details has been published in the peer reviewed Scandinavian Journal of Gastroenterology titled "The advent of the first electric-driven EUS-guided 17-gauge core needle biopsy - A pilot study on subepithelial lesions" (F. Swahn et al.).

The pilot study compared tissue sampling using the EndoDrill GI vs. standard fine needle instrument in deeply situated gastric tumors in 7 patient cases. In each tumor, tissue samples were taken in randomized order with electric-driven EndoDrill GI and with leading fine needle instruments, EUS-FNB (Medtronic, SharkCore(TM)).

With the EndoDrill GI, a rotating needle cylinder cuts out tissue samples, and with the standard EUS-FNB, samples are taken with a manual stabbing motion. It was a broad group of patients (n=7, 28-75 years) with 6 different types of tumors in the upper gastrointestinal tract and with a tumor size from 17 mm to 90 mm, that is a significant challenge for endoscopic sampling. For EndoDrill, samples of visible "core biopsies" were obtained in 7/7 cases (100%) while manual EUS-FNB resulted in 5/7 (71%) samples of ditto.

Histological diagnosis was obtained in 7/7 cases (100%) with EndoDrill and in 6/7 cases (86%) with EUS-FNB. No serious complications were noted after the examinations. EndoDrill was rated as "simple" or "very simple" in terms of handling (7/7), preparation (7/7), adjustment of the needle (7/7), and sampling performance (6/7, one difficult case).

The research team concludes that the pilot study has shown that EndoDrill GI can safely be used to obtain true core biopsies (CNB, Core Needle Biopsy) in a single needle puncture, reducing the need for a second sampling. The authors write that the EndoDrill GI obtained coherent histological tissue samples that superseded conventional FNB samples, in both amount and quality. It is also noted that the EndoDrill needle is hyperflexible, which was particularly beneficial in one of the cases.

The researchers write that EndoDrill GI takes core biopsies that resemble the tissue samples taken with rigid core needles in breast and prostate cancer. If this can be applied to other tumor areas, EndoDrill will also have the potential to become a valuable tool for effective tissue sampling and precise diagnostics beyond the gastrointestinal tract. The authors conclude by stating that they are confident that the learning curve to use EndoDrill GI is relatively short and that the technology can be applied in routine clinical practice.

The article is "peer reviewed" meaning that experts and researchers in the field have reviewed the study and its scientific quality before it is accepted for publication.